IMPACCT: Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

IMPACCT：肌肉骨骼儿科急性护理临床试验的基础设施

• 批准号: 10206779
• 负责人: Joseph A Janicki
• 金额: $ 172.28万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10206779
• 关键词: Address; Affect; American; Anatomy; Anesthesia procedures; Anesthetics; Area; Award; Child; Childhood; Childhood Injury; Client satisfaction; Clinical; Clinical Research; Clinical Trials; Clinical effectiveness; Complication; Conscious Sedation; Consensus; Data Coordinating Center; Development; Distal; Equipoise; Event; Face; Fracture; Future; General Anesthesia; General anesthetic drugs; Grant; Immobilization; Infrastructure; Injury; Intervention; Lead; Leadership; Location; Medial; Medicine; Methods; Modeling; Morbidity - disease rate; Multi-Institutional Clinical Trial; Musculoskeletal; National Institute of Arthritis and Musculoskeletal and Skin Diseases; North America; Observational Study; Operative Surgical Procedures; Orthopedic Surgery; Orthopedics; Outcome Measure; Pain; Participant; Patient Outcomes Assessments; Patient Recruitments; Patients; Phase; Positioning Attribute; Procedures; Protocols documentation; Radius Fractures; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Personnel; Risk; Savings; Sedation procedure; Site; Societies; Surgeon; Surveys; TimeLine; United Kingdom; Unnecessary Procedures; Upper Extremity; Upper Extremity Fracture; Variant; Voting; acute care; bone; bone healing; clinical decision-making; clinical practice; cost; disability; experience; functional disability; functional outcomes; healing; injured; innovation; limb injury; member; operation; pediatric trauma; primary outcome; procedure cost; prospective; recruit; secondary outcome; sedative; symposium; trauma care; treatment strategy; willingness

ABSTRACT The management of two common upper extremity injuries, pediatric medial epicondyle fractures (MEF) and displaced distal radius fractures (DRF), is controversial with high practice variation. The debate largely focusses on whether to reduce these injuries to restore their usual position or to allow the fractures to heal in their injured position with simple immobilization. Observational studies support both reduction and simple immobilization for MEF and DRF. In both injuries, there have been few prospective and no randomized studies evaluating their treatment. Given the widespread variation in practice, children are either undergoing unnecessary procedures and anesthetic events when surgeons opt for reduction under anesthesia/ conscious sedation OR are being undertreated by simple immobilization. Both scenarios are unacceptable in that children face either anesthetic risks and extra costs or poor alignment with potential long term functional disability To address such clinical dilemmas, the Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT) consortium was organized to develop the infrastructure and experience necessary for multicenter randomized clinical trials. IMPACCT’s leadership has expertise in leading multicenter clinical trials and its members represent 32 diverse centers from the Pediatric Orthopaedic Society of North America (POSNA). During the IMPACCT Consensus Conference, participants agreed that that MEF and DRF have the equipoise necessary and are the most pressing clinical controversies. A similar priority-setting study from the United Kingdom identified these questions as important controversies in children’s orthopaedic surgery. POSNA-wide surveys confirmed MEF and DRF treatment variation and surgeons’ willingness to randomize. A multicenter randomized superiority trial of children with MEF and DRF is required to evaluate the clinical effectiveness of reduction under anesthesia/sedation vs. simple immobilization. The central hypothesis of this proposal is that children treated with reduction under general anesthesia (MEF) or conscious sedation (DRF) will have higher patient reported outcome scores compared to those treated with simple immobilization alone. Trials on both fractures will be conducted simultaneously to take advantage of the economy of scale and are similar in terms of anatomic location, outcome measures, and whether an intervention is necessary. Thirty- one sites have agreed to recruit, randomize and treat a total of 688 patients according to the pragmatic protocols. Investigators have partnered with the Trial Innovation Network to increase the efficiency of trial development and execution. NIAMS has awarded this initiative an R34 Clinical Trials Planning Grant. This proposal will support the active study phase when patients are recruited, treated, and followed and when results are analyzed and disseminated. The completion of these trials will provide a framework, infrastructure and experience for future prospective multicenter clinical trials in pediatric orthopaedics as its results guide clinical decision-making.

抽象的 两种常见上肢损伤的治疗：儿童内上髁骨折（MEF） 和移位的桡骨远端骨折（DRF），由于实践差异很大而存在争议。争论主要是 重点是是否减少这些伤害以恢复其通常的位置或让骨折愈合 他们受伤的位置只需简单的固定即可。观察性研究支持简化和简单 MEF 和 DRF 的固定化。对于这两种伤害，很少有前瞻性研究，也没有随机研究 评估他们的治疗。鉴于实践中存在广泛的差异，儿童要么正在经历 当外科医生选择在麻醉/清醒状态下复位时，不必要的手术和麻醉事件 镇静或简单固定治疗不足。这两种情况对于孩子来说都是不可接受的 要么面临麻醉风险和额外费用，要么面临潜在的长期功能障碍 为了解决此类临床困境，肌肉骨骼儿科急性护理临床基础设施 组织试验 (IMPACCT) 联盟是为了开发必要的基础设施和经验 多中心随机临床试验。 IMPACCT 的领导层拥有领先​​的多中心临床试验的专业知识 及其成员代表北美小儿骨科协会的 32 个不同中心 （波斯纳）。在 IMPACCT 共识大会上，与会者一致认为 MEF 和 DRF 有 平衡是必要的，也是最紧迫的临床争议。一项类似的优先级设定研究来自 英国将这些问题视为儿童骨科手术中的重要争议。 POSNA 范围内的调查证实了 MEF 和 DRF 治疗的差异以及外科医生随机化的意愿。 需要对 MEF 和 DRF 儿童进行多中心随机优势试验来评估 麻醉/镇静下复位与简单固定的临床效果。中心假设 该提案的主要内容是，在全身麻醉（MEF）或清醒镇静下接受复位治疗的儿童 与简单固定治疗的患者相比，（DRF）患者报告的结果分数更高 独自的。两种骨折的试验将同时进行，以利用规模经济和 在解剖位置、结果测量以及是否需要干预方面相似。三十- 一个站点已同意根据务实原则招募、随机分组并治疗总共 688 名患者 协议。研究人员与试验创新网络合作以提高试验效率 开发和执行。 NIAMS 已向该计划授予 R34 临床试验规划补助金。这 该提案将支持积极的研究阶段，即招募、治疗和随访患者以及何时 结果得到分析和传播。 这些试验的完成将为未来提供框架、基础设施和经验 儿科骨科前瞻性多中心临床试验，其结果指导临床决策。